# K132770: DOME S10

- Pathway: 510(k) (Traditional)
- Applicant: Nds Surgical Imaging
- Decided: Jan 30, 2014 after 148 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K093197 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093197: Coronis Fusion 10MP, Model MDCG-10130, Barco N.V. (2010) Summary page 1.

## Indications for use
The Model SI10 is intended for use in displaying and viewing radiography images for review and analysis by trained medical practitioners, and for use in mammography display systems.

Source page: https://510kreport.com/device/K132770
Methodology: https://510kreport.com/methodology